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Comparison of Two Daily Dose Regimens of Tiotropium 5 µg Once Daily and Tiotropium 2.5 µg Twice Daily for 4 Weeks on Top of Maintenance Therapy With Inhaled Corticosteroid Controller Medication

NCT01696071 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2014-08-13

Study results available
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Summary

Determine the 24-hour FEV1-profile of tiotropium solution for inhalation after 4 weeks treatment periods of 5 mcg tiotropium administered once daily in the evening and 2.5 mcg tiotropium administered twice daily (morning and evening). In addition compare the 24 hours pharmacokinetic profile of 5 mcg tiotropium administered once daily and 2.5mcg tiotropium administered twice daily in pharmacokinetic sub-investigation.

Conditions

Interventions

DRUG

Tiotropium 5 mcg qd

2 puffs (2.5 mcg each) in the evening 5 mcg in total and 2 puffs of matching placebo in the morning

DRUG

Tiotropium 2.5 mcg bid

2 puffs (1.25 mcg each) twice daily, in the evening and in the morning, 5 mcg in total

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • Austria
  • Germany
  • Hungary
  • Slovenia

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01696071 on ClinicalTrials.gov